Phase 1 Trial To Evaluate mFOLFOX6 With Selinexor In Patients With Metastatic Colorectal Cancer

Phase 1 Terminated 10 enrolled GSO Global Clinical Research BV Karyopharm Therapeutics Inc · collab

NaSequentialOpen-labelTreatment

Summary

This trial will evaluate the combination treatment of established chemotherapy regimen mFOLFOX6 with Selinexor, an oral Selective Inhibitor Of Nuclear Export, in patients with metastatic Colorectal Cancer. The purpose is to determine the maximum tolerated dose (MTD) of selinexor in combination with mFOLFOX6.

Timeline

Start: 2015-03
Primary completion: 2017-03-09
Completion: 2017-03-09

Publications

Nilsson S, Stein A, Rolfo C, Kranich AL, Mann J, Papadimitriou K, Theile S, Amberg S, Bokemeyer C. Selinexor (KPT-330), an Oral Selective Inhibitor of Nuclear Export (SINE) Compound, in Combination with FOLFOX in Patients with Metastatic Colorectal Cancer (mCRC) - Final Results of the Phase I Trial SENTINEL. Curr Cancer Drug Targets. 2020;20(10):811-817. doi: 10.2174/1568009620666200628105727.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Selinexor	Other / unclassified	20 mg	—
Subject	Selinexor	Other / unclassified	40 mg	—
Subject	Selinexor	Other / unclassified	60 mg	—
Subject	Selinexor	Other / unclassified	80 mg	—
Background	Leucovorin	Small molecule	400 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	fluorouracil	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous

Phase 1 Trial To Evaluate mFOLFOX6 With Selinexor In Patients With Metastatic Colorectal Cancer

Summary

Timeline

Publications

Drugs

Indications